- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02024425
Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)
A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals
연구 개요
상세 설명
A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.
Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Madrid, 스페인, 28061
- Hospital Universitario La Paz
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women from 45 to 75 years old;
- Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
- Signed informed consent.
Exclusion Criteria:
- Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
- Subjects with Diabetes Mellitus insulin dependent;
- Individuals that stop smoking in the next 12 weeks (during the study);
- Subjects with increased alcohol consumption (> 1 glass of vine);
- Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
- Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
- Subjects with disorders associated with eating behaviour;
- Subjects with drugs or supplements consumption to weight lost;
- Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
- Subjects who refuse to perform the indicated dietary changes throughout the study;
- Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.);
- Subjects with mental disease or low cognitive function;
- Subjects with severe diseases (hepatic, kidney, cancer…);
- Pregnant women or lactating;
- Subjects with physical problems complying with the recommendations of physical activity.
- Subjects with intensive physical activity;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Functional bioactive supplement
The functional bioactive supplement is composed of antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides.
It will be used for obese and overweight treatment
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1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
다른 이름들:
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위약 비교기: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose .
It has no effect for obese and overweight treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in body composition
기간: 12 weeks
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Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Life style and health status: Life style and physical activity questionnaire
기간: Week 0 and Week 12
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Week 0 and Week 12
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Genetic analysis
기간: Week 0 and Week 12
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Week 0 and Week 12
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Metabolomic analyses
기간: Week 0 and Week 12
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Week 0 and Week 12
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Endothelial function markers
기간: Week 0 y Week 12
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Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
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Week 0 y Week 12
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Satiety hormones
기간: Week 0 y Week 12
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Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
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Week 0 y Week 12
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Inflammatory markers
기간: Week 0 and Week 12
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Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
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Week 0 and Week 12
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Glucose Metabolism
기간: Week 0 and Week 12
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Glucose Metabolism: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5)
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Week 0 and Week 12
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Lipid profile: Cholesterol
기간: Week 0 and Week 12
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Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
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Week 0 and Week 12
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Oxidative Stress Parameters
기간: Week 0 and Week 12
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Oxidative Stress Parameters: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, PON1, F2-isoprostanes
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Week 0 and Week 12
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Adverse effects
기간: 0 , 3, 6, 9 and 12 weeks
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Adverse effects: transaminases and creatinine
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0 , 3, 6, 9 and 12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Appetite and satiety
기간: 0 , 3, 6, 9 and 12 weeks
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0 , 3, 6, 9 and 12 weeks
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Frequent daily evacuations
기간: 4 Weeks
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Frequent daily evacuations, format and consistency of the feces, total and segmental transit time.
The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools)
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4 Weeks
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Adherence and Tolerance Parameters
기간: 0 , 3, 6, 9 and 12 weeks
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Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
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0 , 3, 6, 9 and 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Carmen Gomez Candela, PhD, Hospital Universitario La Paz
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ALIBIRDII
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